The Smith & Nephew Control Digital Operating Room System is indicated for use with compatible endoscopic and surgical equipment for centralized control of these devices and display of device status. The control system provides centralized touch panel and voice control of medical devices for use by the surgeon and O.R. staff.

Device Description

The proposed Smith & Nephew Control Digital Operating Room System is a computer based system that enables centralized status display and control of multiple medical and non-medical devices through touch panel activation or through an optional voice recognition feature. The primary system consists of a Medical Device Controller, Medical Device Hub, Primary Touch Panel Interface (TPI-P), Surgical Touch Panel Interface (TPI-S), Ethernet Router and AVB network hub and AVB Power Supply. Optional components include: speech recognition engine, a wireless microphone for speech recognition, a wireless touch screen interface that can be bagged and placed in the sterile field, a display controller which allows device settings and conditions to be displayed on the surgeon's monitor.

AI/ML Overview

Here's an analysis of the provided text regarding the Smith & Nephew Control Digital Operating Room System, addressing the requested information:

1. Table of Acceptance Criteria & Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance	Study Proving Performance
Safety	IEC 60601-1 (1988) + Amd 1 (1991) + Amd 2 (1995) (UL 2601-1)	Conforms to standard	Performance testing (general statement)
	IEC 60601-1-1 (1992) + Amd 1 (1995), (2000)	Conforms to standard	Performance testing (general statement)
	UL 60601-1 (2003)	Conforms to standard	Performance testing (general statement)
	CAN/CSA 22.2 No. 601.1 (1990) + Supp 1-94 (1994)	Conforms to standard	Performance testing (general statement)
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 (2001-09) 2nd Edition	Conforms to standard	Performance testing (general statement)
Functional Equivalence	Centralized and remote control of medical devices in the O.R. equivalent to predicate devices.	Demonstrates substantial equivalence to Olympus EndoALPHA, HERMES, and Sidne™ systems.	Summary Performance Data (general statement)

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The submission references "performance testing" but does not detail the methodology, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature) for any specific tests performed beyond adherence to general safety and EMC standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The submission focuses on substantial equivalence to predicate devices and adherence to regulatory standards, not on clinical-performance-based ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the device (a control system for existing medical devices) and the focus on substantial equivalence to predicate devices and adherence to regulatory standards, a formal adjudication method for a "test set" in the sense of clinical image or data interpretation is unlikely to have been a primary component of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided and is not applicable to this device. The Smith & Nephew Control Digital Operating Room System is a control system for medical devices, not an AI-powered diagnostic or interpretive tool that would involve "human readers" or "AI assistance" in the typical MRMC study context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not provided and is not entirely applicable in the context of an algorithm's interpretive performance. The device itself is a standalone system for controlling other medical devices. Its "performance" would be assessed in terms of its ability to correctly send commands and display status, which is inherent in its function. No separate "algorithm-only" study examining diagnostic accuracy (as typically implied by this question) would be relevant here.

7. The Type of Ground Truth Used

The "ground truth" used for this submission appears to be:

Adherence to recognized voluntary standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, UL 60601-1, CAN/CSA 22.2 No. 601.1 regarding safety and EMC.
Functional equivalence to predicate devices: The ability of the system to provide "centralized and remote control of medical devices in the O.R." in a manner deemed equivalent to existing, legally marketed systems (Olympus EndoALPHA, HERMES, Sidne™). This implies that the accepted functionality of the predicate devices serves as a benchmark for "ground truth" performance.

No pathology, expert consensus on diagnostic outcomes, or patient outcomes data is mentioned as ground truth.

8. The Sample Size for the Training Set

This information is not provided in the document. As this is a control system for operational devices rather than a machine learning algorithm that is "trained" on data to perform a specific task (e.g., image classification), the concept of a "training set" in the context of AI/ML is not applicable here. Its development would involve software engineering and hardware testing, not a data-driven training process.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable for the reasons stated in point 8.

Summary

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975 749 1000 973 749 1599 Fax www.smith-nephow.com

NOV 2 3 2005

We are smith&nephew
K050209

SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew Control Digital Operating Room System

Date Prepared: January 27, 2005

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

B. Company Contact

Janice Haselton Regulatory Affairs Specialist Phone: (978) 749-1494 Fax: (978) 749-1443

C. Device Name

Trade Name:	Smith & Nephew Control Digital Operating Room System
Common Name:	Endoscopes and accessories, Arthroscopes, Electrosurgicalcutting and coagulation device and accessories
Classification Name:	General and Plastic Surgery, Orthopedic,Gastroenterology/Urology

D. Predicate Devices

The Smith & Nephew Control Digital Operating Room System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Olympus EndoALPHA

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Integrated Endosurgery System, cleared in K981993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne™ System, cleared in K022393.

Description of Device E.

Optional components include:

speech recognition engine ●
a wireless microphone for speech recognition .
a wireless touch screen interface that can be bagged and placed in the . sterile field
. a display controller which allows device settings and conditions to be displayed on the surgeon's monitor

F. Intended Use

G. Comparison of Technological Characteristics

The Smith & Nephew Control Digital Operating Room System is substantially equivalent to the Olympus EndoALPHA Integrated Endosurgery System, cleared in K981993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne™ System, cleared in K022393 based on the following similarities:

a central controller which monitors and controls various medical devices .
a centralized control panel which displays various medical devices used in . the operating room
remote control of various medical devices via a touch screen panel ●
. voice activation and control of various medical devices used in the operating room

H. Summary Performance Data

The performance testing conducted on the Smith & Nephew Control Digital. Operating Room System demonstrates substantial equivalence to the Olympus

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EndoALPHA Integrated Endosurgery System, cleared in K981993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne™ System. cleared in K022393 based on equivalent performance outcomes of centralized and remote control of medical devices in the O.R.

The Smith & Nephew Control Digital Operating Room System conforms to the following voluntary standards:

IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety (1988) + Amendment 1 (1991) + Amendment 2 (1995) (UL 2601-1)

IEC 60601-1-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, Safety Requirements for Medical Electrical Systems (1992) + Amendment 1 (1995), (2000)

IEC 60601-1-2 (2001-09) 2nd Edition Medical Electrical Equipment - Part I: General Requirements for Safety; Electromagnetic Compatibility - Requirements & Tests (2001)

UL 60601-1 (2003): Medical Electrical Equipment - Part 1: General Requirements for Safety

CAN/CSA 22.2 No. 601.1 Medical Electrical Equipment - Part 1: General Requirements for Safety (1990) + Supplement No. 1-94 (1994)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.

NOV 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janice Haselton, Sr. Regulatory Affairs Specialist Smith & Nephew, Inc. 150 Minuteman Road Andover, Massachusetts 01810

Re: K050209

K030207
Trade/Device Name: Smith & Nephew Control Digital Operating Room System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 17, 2005 Received: October 18, 2005

Dear Ms. Haselton:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatinent date of the Medical Device Amendments, or to conninered print to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic recry there the device, subject to the general controls provisions of the Act. The 1 ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controls profice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast of advised that I Dr o toseantes over device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I caeral statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or N in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualify of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Janice Haselton

This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier will anow you to ough finding of substantial equivalence of your device to a legally premarket notification "The results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific daries in (240) 276-0115 . Also, please note the regulation entitled, Contact the Ories of Companisemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Kaubere Invelun

Mark N. Melkersen Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

1050209

Device Name: __ The Smith & Nephew Control Digital Operating Room System__

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ------

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buehler MXM
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K050209

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.